Warning letter

Impax Laboratories, Inc [ARCHIVED]: warning letter of May 31, 2011

FDA warning letter 172752 · San Francisco District Office

Key facts

Reference number 172752
Company Impax Laboratories, Inc [ARCHIVED]
Subject CGMP for Finished Pharmaceuticals/Adulterated
Issue date May 31, 2011
Posted date May 31, 2011
Issuing office San Francisco District Office
Product type Drugs
CFR sections cited 211.110(a), 211.192
Inspection city Hayward
Inspection ZIP 94544
Inspection start date Dec 13, 2010
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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